Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects

This study has been completed.

First Received: December 19, 2006 Last Updated: January 14, 2008 History of Changes

Sponsors and Collaborators:	Novartis Procter and Gamble
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00413790

Purpose

This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older

Condition	Intervention	Phase
Healthy	Drug: Darifenacin Drug: Tolterodine Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	A 3-Way Cross-Over, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Pharmacologic Effects of a 7-Day Exposure to Darifenacin 15 mg o.d. and Tolterodine ER 4 mg o.d on Cardiovascular Parameters in Healthy Subjects 50 Years of Age and Older

Resource links provided by NLM:

Drug Information available for: Tolterodine Tolterodine tartrate Darifenacin Darifenacin hydrobromide

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Mean heart rate per 24 hours following exposure to darifenacin 15 mg o.d. and tolterodine ER 4 mg o.d., at baseline and Day 7

Secondary Outcome Measures:

Effects of darifenacin and tolterodine compared to placebo on mean heart rate per 24 hours, at baseline and Day 7
Effects of darifenacin, tolterodine and placebo on other cardiovascular parameters at baseline and Day 7

Enrollment:	162
Study Start Date:	November 2006
Study Completion Date:	September 2007

Arms	Assigned Interventions
1: Experimental Darifenacin	Drug: Darifenacin Darifenacin tablets 15 mg once daily
2: Active Comparator Tolterodine	Drug: Tolterodine Tolterodine extended release (ER) 4 mg once daily
3: Placebo Comparator Placebo	Drug: Placebo Placebo tablet once daily

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Healthy males and females ≥ 50 years
Body mass index equal to or greater than 18.5 kg/m2 and less than 35.0 kg/m2

Exclusion Criteria:

Known or suspected allergy to tolterodine ER or darifenacin or their components
Subjects with irregular day and night patterns such as night shift workers
Significant medical problems know to affect heart rate (ie., hypertension, hypotension, history of heart failure, history of pulmonary disease, etc.)
History of any malignancy within the past 5 years, with the exception of localized basal cell carcinoma of the skin
Pregnant or nursing women
Subjects with diseases such as urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, severe renal insufficiency, etc.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413790

Locations

United States, Arizona
Investigative Site
Scottsdale, Arizona, United States, 85251
Investigative Site
Tempe, Arizona, United States, 85282
United States, California
Investigative Site
San Diego, California, United States, 92103
United States, Florida
Investigative Site
Jupiter, Florida, United States, 33458
Investigative Site
Jacksonville, Florida, United States, 32216
United States, Kansas
Investigative Site
Overland Park, Kansas, United States, 66215
United States, Kentucky
Investigative Site
Madisonville, Kentucky, United States, 42431
United States, Massachusetts
Investigative Site
Wellesley Hills, Massachusetts, United States, 02481
United States, New Jersey
Investigative Site
Hackensack, New Jersey, United States, 07601
United States, New York
Investigative Site
Buffalo, New York, United States, 14202
United States, Texas
Investigative Site
Dallas, Texas, United States, 75235
Investigative Site
Austin, Texas, United States, 78752

Sponsors and Collaborators

Novartis

Procter and Gamble

Investigators

Study Chair:

Novartis Pharmaceuticals Corp.

NPC

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CDAR328A2413
Study First Received:	December 19, 2006
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00413790 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Heart rate, overactive bladder

Study placed in the following topic categories:

Muscarinic Antagonists
Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists

Darifenacin
Healthy
Cholinergic Agents
Tolterodine

Additional relevant MeSH terms:

Muscarinic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Darifenacin

Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions
Tolterodine

ClinicalTrials.gov processed this record on September 11, 2009